Liletta LNG IUS

Alternative Name: Levosert (U.K.); Erlacela (Portugal); Donasert (Romania); Avibela

Description: LILETTA is the brand name for the levonorgestrel-releasing intrauterine system (LNG-IUS) marketed by Medicines360 and Actavis in the U.S., where it is approved for 3 years of use for contraception.

Product Details

User: Female

Hormonal: Yes

Delivery Method: Intrauterine

Duration Type: Long-acting

Duration: 4 years

Dose: 52 mg

Active Pharmaceutical Ingredient (API):
  • levonorgestrel

Inactive material: drug reservoir is silicone base; T-frame is low density polyethylene (LDPE), etc. See footnote

Multipurpose Preventive Technology (MPT): No

Status Details

Developer: Actavis, Medicines360

Project Phase: Limited Market Availability

Development Stage: SRA/WHO PQ Approved

Active Development: Yes

Status Details:
  • Medicines360 received U.S. FDA approval for Liletta in February 2015, with a use duration of 3 years. The product launched in the U.S. in April 2015. Medicines360 and Allergen filed a supplemental new drug application to the US FDA to extend Liletta's use duration to 4 years; the application was approved in August 2017.
  • The product is also approved in more than a dozen countries in Europe, including in the U.K. for 3 years of contraception and treatment of menorrhagia.
  • In 2014, a public-private partnership was launched between Medicines360, FHI 360 and Marie Stopes International (MSI) to support the development of an introduction strategy for the product in Kenya.
  • A study of Liletta's effectiveness over the course of ten years is underway. Preliminary results published after 5 years indicating Liletta is still effective at 5 year mark.

Additional Information

References:

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